U.S. patent application number 16/360541 was filed with the patent office on 2020-09-24 for lacrimal plug inserter.
The applicant listed for this patent is James Aman, Jeffrey Cheesman, Michael A. Singer. Invention is credited to James Aman, Jeffrey Cheesman, Michael A. Singer.
Application Number | 20200297535 16/360541 |
Document ID | / |
Family ID | 1000003989423 |
Filed Date | 2020-09-24 |
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United States Patent
Application |
20200297535 |
Kind Code |
A1 |
Singer; Michael A. ; et
al. |
September 24, 2020 |
Lacrimal Plug Inserter
Abstract
A medical instrument and method is described for facilitating
lacrimal occlusion. The instrument has two arms for holding a plug
being inserted through the punctum, each arm having a distal end
and a proximal end. Attached to the proximal end of the arms is a
dilator oriented in the opposite direction along the longitudinal
axis of the instrument. The instrument is conveniently rotated in
the hand of the practitioner to alternately present the functioning
end of the instrument as either the distal end of the arms (for
holding a plug) or the distal end of the dilator (for enlarging the
punctum prior to attempting to inserting the plug). The instrument
has a means for moving the two arms near to each other and away
from each, and a means for holding the two arms near to each other
without requiring closing pressure applied by the practitioner.
Inventors: |
Singer; Michael A.; (San
Antonio, TX) ; Cheesman; Jeffrey; (Upper Saddle
River, NJ) ; Aman; James; (Poinciana, FL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Singer; Michael A.
Cheesman; Jeffrey
Aman; James |
San Antonio
Upper Saddle River
Poinciana |
TX
NJ
FL |
US
US
US |
|
|
Family ID: |
1000003989423 |
Appl. No.: |
16/360541 |
Filed: |
March 21, 2019 |
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 2017/1205 20130101;
A61F 9/00772 20130101; A61B 17/12099 20130101; A61M 29/00 20130101;
A61B 17/12159 20130101 |
International
Class: |
A61F 9/007 20060101
A61F009/007; A61B 17/12 20060101 A61B017/12 |
Claims
1. A medical instrument for facilitating the treatment of dry eye
using lacrimal occlusion, where the instrument further comprises:
two arms, wherein each arm comprises a proximal portion, a wide
portion, a narrow portion and a distal portion, where each of the
proximal portions of the arms are joined forming a base, where each
of the wide portions together provide a grasping surface, where
each of the narrow portions together form an inflection point, and
where each of the distal portions together form a holding surface
for engaging and disengaging a plug; a dilator, where the dilator
comprises a proximal end attached to the base and a distal end
extending therefrom.
2. The instrument of claim 1 wherein the dilator is further adapted
with a profile for use as a sizer-dilator.
3. The instrument of claim 2 wherein the profile of the
sizer-dilator is further adapted to include markings indicative of
plug sizes.
4. The instrument of claim 2 wherein the base is further adapted to
include means for accepting a detachable dilator or a detachable
sizer-dilator, and wherein the dilator or sizer-dilator is further
adapted to be detachable and includes mean for attaching to the
base.
5. The instrument of claim 1 wherein the tips of the distal ends of
the holding surface are provided in any of various shapes and
sizes.
6. The instrument of claim 5 wherein either one or both of the
distal ends of the holding surface are further adapted to
individually include or collectively form a receptacle for
maneuvering a plug.
7. The instrument of claim 1 further comprising one or more
detachable distal end tips, wherein either one or both of the
distal ends of the holding surface is further adapted to include
means for accepting a detachable distal end tip, and wherein the
detachable distal end tip includes means for attaching to the
accepting means.
8. The instrument of claim 1 further comprising one or more
detachable tip sleeves, wherein a tip sleeve substantially fits
over a distal end, wherein either one or both of the distal ends of
the holding surface is further adapted to include sleeve securing
means for securing a detachable tip sleeve, and wherein the
detachable tip sleeve includes companion distal end securing means
for securing to the distal end's tip sleeve securing means.
9. The instrument of claim 8 for use in a replaceable tip sleeve
system, where the system comprises the medical instrument and at
least one tray, where a tray provides a storage location for
storing a detachable tip sleeve, where access to the storage
location includes an impeded path and an unimpeded path, wherein a
distal end currently without an engaged tip sleeve is first
inserted into the impeded path to engage a respective tip sleeve
being held within a respective storage location and second
extracted through the unimpeded path to remove the now currently
engaged tip sleeve, and wherein a distal end currently with an
engaged tip sleeve is first inserted into the unimpeded path to
place the respective tip sleeve into a respective storage location
and second extracted through the impeded path to disengage the tip
sleeve from the distal end and remove the distal end from the
tray.
10. The instrument and system of claim 9 wherein the box is sloped
with respect to the longitudinal axis of the box, where the
longitudinal axis of the box lies substantially parallel with the
longitudinal axis of the tip sleeve storage locations and
substantially perpendicular to the unimpeded path, where the first
height of the box with respect to the perpendicular path is greater
at the entrance to the impeded path, and where the second height of
the box with respect to the perpendicular path is less than the
first height at the end of the box that is opposite to the entrance
to the impeded path.
11. The instrument and system of claim 9 further comprising a rack,
where the rack comprises two or more trays.
12. The instrument of claim 1 that has been further adapted to
include mechanical means for limiting the closing pressure of the
instrument.
13. The instrument of claim 12, wherein the mechanical means for
limiting the closing pressure of the instrument include any of:
screw type means, sliding wedge type means, rotating oblong wheel
type means or pivoting rachet arms type means.
14. The instrument of claim 1 further comprising: a separator for
limiting the maximum separation distance between the distal
portions of each arm caused by opening pressure applied to the wide
portions of each arm.
15. The instrument of claim 1 wherein the outer surfaces of the
wide portion of each arm include surface changes for increasing
grip.
16. A method of performing lacrimal occlusion using the medical
instrument of claim 1, comprising the steps of: grasping the
grasping surface of the medical instrument; when needing to dilate
the punctum of a patient, orienting the dilator of the medical
instrument such that the dilator is the functioning end of the
instrument and using the dilator to dilate the punctum of the
patient; when needing to engage a plug for insertion into the
punctum of the patient, orienting the holding surface of the
medical instrument such that the holding surface is the functioning
end of the instrument, applying opening pressure on the grasping
portion of the instrument sufficient to cause the holding surface
to separate by a distance greater than the portion of the plug to
be engaged, releasing the opening pressure to cause a closing
pressure whereby the holding surface engages the plug; when needing
to insert an engaged plug into the punctum of the patient,
orienting the holding surface of the medical instrument such that
the holding surface is the functioning end of the instrument and
directing the plug as currently engaged by the holding surface into
the punctum, and when needing to disengage a plug from the holding
surface, applying opening pressure on the grasping portion of the
medical instrument sufficient to cause the holding surface to
separate by a distance greater than the portion of the plug
currently engaged such that the plug is no longer touching the
holding surface.
17. The method of claim 16 wherein the medical instrument is
further adapted to include a sizer-dilator with a sizer profile,
further comprising the step of: when needing to determine a size of
a plug, orienting the sizer-dilator of the medical instrument such
that the sizer-dilator is the functioning end of the instrument and
using the profile of the sizer-dilator to penetrate the punctum of
the patient for determining a plug size.
18. The method of claim 17 where the profile of the sizer-dilator
has been further adapted to including size markings, wherein the
step for needing to determine a size of a plug is further adapted
such that the sizer-dilator size marking corresponding the
determined plug size is remembered, and wherein possible plugs for
use in the patient include plug size markings correlated with the
sizer-dilator size markings, further comprising the step of: when
needing to select a plug for insertion into the patient, selecting
the plug with a plug size marking that best correlates with the
remembered sizer-dilator marking.
19. The method of claim 16 wherein the medical instrument is
further adapted to include clamp-limiting means, further comprising
the step of: adjusting the clamp-limiting means prior to or while
engaging the plug.
20. The method of claim 16 wherein the medical instrument is
further adapted to include means for attaching a detachable dilator
or sizer-dilator, further comprising the step of: prior to either
dilating the patient's punctum with the dilator or the
sizer-dilator, or sizing the patient's punctum with the
sizer-dilator, attaching the detachable dilator or sizer-dilator to
the medical instrument's dilator or sizer-dilator attaching
means.
21. The method of claim 16 wherein the holding surface of the
medical instrument is further adapted to include a plug receptacle
for maneuvering the plug, further comprising the step of: when
needing to further insert a disengaged plug into the punctum of the
patient, orienting the holding surface of the medical instrument
such that the holding surface is the functioning end of the
instrument, engaging the end of the plug protruding from the
patient's punctum with the receptacle and directing the plug as
currently engaged by the receptacle into the punctum.
22. The method of claim 16 wherein the medical instrument is
further adapted to include means for attaching a detachable distal
end tip, further comprising the step of: prior to engaging an
object to be engaged by the holding surface, attaching the
detachable distal end tip to the medical instrument's distal end
tip attaching means.
23. The method of claim 16 wherein the medical instrument is
further adapted to include securing means for securing a detachable
tip sleeve, further comprising the step of prior to engaging an
object to be engaged by the holding surface, securing the
detachable tip sleeve to the medical instrument's distal end tip
securing means.
24. The method of claim 23 wherein the medical instrument is used
within a replaceable tip sleeve system, where the system comprises
the medical instrument and at least one tray, where a tray provides
a storage location for storing a tip sleeve, where access to the
storage location includes an impeded path and an unimpeded path,
further comprising the steps of: prior to engaging an object to be
engaged by the holding surface, at which time a distal end of the
holding surface is not currently engaging a respective tip sleeve,
first inserting the distal end of the holding surface into the
impeded path to engage a respective tip sleeve being held within a
respective storage location and second extracting the distal end
now engaging the respective tip sleeve through the unimpeded path
to remove the now currently engaged tip sleeve, and at a time where
a distal end of the holding surface is currently engaging a
respective tip sleeve, first inserting the distal end currently
engaging the tip sleeve into the unimpeded path to place the
respective tip sleeve into a respective storage location and second
extracting the distal end through the impeded path to disengage the
tip sleeve from the distal end and remove the distal end from the
tray.
Description
FIELD OF THE INVENTION
[0001] The present invention relates, in general, to medical
instruments and methods which facilitate the occlusion of the
lacrimal duct by the insertion of either an intracanalicular or
punctal plug. More particularly, it relates to a single lacrimal
plug inserter that provides for both the functions of punctal
dilation and plug engagement, insertion and disengagement, thereby
providing more efficient and robust treatment methods.
BACKGROUND OF THE INVENTION
[0002] Dry eye is a common ailment for which there are different
treatments including what is known in the art as lacrimal
occlusion, where lacrimal refers to the lacrimal puncta which are
small openings in the tear duct for draining tears secreted by the
lacrimal gland and occlusion refers to the blocking of these ducts
by the insertion of small plugs. An individual duct is referred to
as a punctum, for which there are two basic types of occlusions;
the first referred to as punctal occlusion and the second as
intracanalicular occlusion. With punctal occlusion, a practitioner
inserts into the punctum a punctal plug, usually including a
flanged end, where the plug inserts into the punctum up to the
flange but no further, thus leaving the flange exposed facilitating
the extraction of the punctal plug if necessary, by allowing the
plug to be pulled out from the punctum by the flange end. In the
second type of intracanalicular occlusion, a practitioner inserts
into and through the punctum an intracanalicular plug not including
a flanged end, such that the intracanalicular plug can be pushed
into the interior of the lacrimal (tear) duct referred to as the
canaliculus.
[0003] In either type of occlusion, the plugs typically range in
diameter between 0.4 mm and 0.8 mm and in price from $50 to over
$250. In the most common type of lacrimal occlusion procedure
having been practiced for over the last 40 plus years, three
separate instruments are required, namely: 1) a punctal sizer, 2) a
dilator, and 3) thumb forceps, all of which are well-known in the
art. The procedure is typically performed by a practitioner without
the aid of an assistant, and as such it is necessary that the
practitioner switch their gaze between a concentration on the
patient's punctum and a concentration on the selecting of
instruments necessary for performing the occlusion, and more
specifically switching between a dilator instrument and the thumb
forceps during the more critical insertion portion of the process.
The sizer instrument is used prior to the plug insertion process to
help determine the size of the patient's punctum and therefore the
diameter of an appropriate plug. The plug insertion process
typically commences with the practitioner using the dilator tool to
enlarge the orifice of the punctum after which the practitioner
puts down the dilator instrument, picks up the thumb forceps, and
then uses the thumb forceps to select the proper plug. After
selecting the plug, the practitioner maintains a grasp of the plug
by continuing to put a closing pressure on the thumb forceps, while
then at the same time moving the plug to the punctum and then
inserting the plug into the punctum. Once successfully inserted,
the practitioner releases the applied closing pressure on the thumb
forceps disengaging the plug that is partially inserted into the
punctum. After releasing, the practitioner typically uses the
distal end of the thumb forceps to further push the plug into the
punctum as required by the type of plug. For a single patient, it
is often necessary for the practitioner to insert multiple plugs,
thus increasing the overall duration and cost of the procedure.
[0004] In this typical lacrimal occlusion process, there are
several drawbacks including: 1) the plugs are small and somewhat
soft (based upon their material composition, for example being
collagen for temporary plugs or silicone for longer lasting plugs),
where the combination of size and softness increases the dexterity
required of the practitioner to apply the sufficient closing force
for grasping the plug without excessive force that could damage the
plug; 2) while applying the sufficient closing force and
simultaneously moving the plug towards and into the punctum, it is
not uncommon to drop the plug, where the loss of plugs is
expensive, increases the mental stress of both the practitioner and
the patient as the entire process duration is increased, and 3)
when attempting to insert the plug, it is not uncommon that the
practitioner determines that the punctum requires further dilation,
thus requiring that the practitioner first disengage the plug by
releasing the closing pressure on the thumb forceps, put down the
forceps, pick up the dilator instrument, dilate the punctum, put
down the dilator instrument, pick up the forceps, reengage the plug
and attempt to again insert the plug, the combination of steps of
which both add mental stress to the practitioner and patient,
increase the duration of the process, increase the likelihood of
dropping the plug, and distract the practitioner as they switch
their gaze away from the patient's punctum.
BREIF SUMMARY OF THE INVENTION
[0005] The present invention is a new medical instrument that
combines the functions of bulldog forceps in combination with a
dilator, thus providing a single instrument replacing the
traditional two instruments including a separate dilator and
separate thumb forceps. Unlike the thumb forceps which require a
continuous closing pressure to be applied by the practitioner in
order to maintain engagement of a plug, bulldog forceps only
require an opening pressure (which is then relaxed) to engage the
plug and an opening pressure to then disengage the plug (after
insertion into the punctum). After applying opening pressure to
separate the distal ends of the bulldog forceps in the process of
surrounding the plug for engagement by the distal ends, the
practitioner releases the opening pressure (or inversely stated
applies closing pressure) that allows the distal ends to converge
and engage the plug. Once so engaged, the positive pressure
inherent between the distal ends of the bulldog forceps maintains
the grasp of the plug without requiring any additional pressure
from the practitioner (e.g. closing pressure if using thumb
forceps). This removal by the present invention of the need for the
practitioner to maintain an additional pressure offers many
benefits to be described herein.
[0006] The presently described medical instrument also includes a
dilator on the end of the instrument opposite to the distal end of
the bulldog forceps (used for engaging a plug), where the distal
end of the combined instrument is the functioning end of the
instrument and always closest to the patient's punctum for the
purposes of inserting or adjusting a plug. Given this two-in-one
instrument, with a simple rotation of the instrument, the dilator
that was proximal becomes distal and therefore also the functioning
end. Conversely, with a second rotation of the instrument, the
bulldog forceps distal ends become the distal and functioning end
of the instrument. Given this convenient arrangement of not
requiring additional pressure applied by the practitioner and
including a dilator with the instrument easily accessed by a simple
rotation of the instrument, it is now possible for the practitioner
to: 1) be able to make the more delicate hand movements required
for efficiently inserting the plug because the only physical hand
exertion is to handle and move the instrument (and not also to
additionally keep the distal ends of the instrument closed and
engaging the plug as with thumb forceps), 2) be less concerned with
dropping or damaging plugs as with the use of thumb forceps since
the bulldog forceps maintain the appropriate continuous closing
pressure without further concentration or effort from the
practitioner, and 3) be able to switch from attempting to insert
the plug to further dilating the punctum, and then back to
attempting to insert the plug using a single tool simply rotated in
the practitioner's hand, where then the practitioner is not
required to divert their gaze from the patient's punctum thus
improving the process and minimizing the process duration.
[0007] The present invention provides for further adaptations such
that the two-in-one instrument becomes a three-in-one instrument,
wherein the traditional function provided by a separate
punctal-sizer is incorporated into the instrument's dilator, thus
becoming a sizer-dilator. Hence, whereas a traditional lacrimal
occlusion procedure requires three instruments including a punctal
sizer, a dilator, and thumb forceps, the further adapted present
invention provides each of these functions in a single convenient
tool, thus saving valuable processes time for the practitioner,
where this reduction in process time at least reduces the mental
stress on the patient.
[0008] Other adaptations are provided for allowing the herein
taught medical instrument to support a multiplicity of detachable
end tips or end tip sleeves for engaging at least the punctal
plugs, or a multiplicity of detachable dilators or detachable
sizer-dilators for dilating the punctum and sizing the punctum.
Using these further adaptations for detachable proximal or distal
ends, it is also shown that the instrument is useful for at least
other medical procedures such as trichiasis using a cilia style end
tip and is also anticipated to be useful for other non-medical
processes. With respect to the detachable end tip sleeves, the
present invention teaches a new rack comprising one or more boxes,
each box comprising two trays, each tray for holding a sleeve for
use with a distal end of the instrument. In combination with the
herein taught medical instrument, the rack, box and tray solution
provides a convenient way for the practitioner to quickly select,
replace or switch between a number of different end tips using only
a single hand, thus further facilitating the optimization of at
least medical procedures such as lacrimal occlusion.
[0009] And finally, the herein taught bull-dog mechanism is further
adapted with various mechanical clamp-limiting means such that the
practitioner can decrease the maximum clamping pressure the
instrument will inherently provide, offering advantages in
situations such as where the grasped material is of a softer
composition for which the inherent closing pressure of the
instrument is ideally limited to avoid possible damage to the
material. At least one variation of the herein taught
clamp-limiting mechanisms is shown to conveniently allow the
practitioner to use the end tips in a separation function as
opposed to a grasping function, for example to provide tissue
separation and holding during a medical procedure such that the
practitioner can then have access to the patient through the gap
opened in the tissue.
[0010] As will be discussed with greater detail herein, the present
invention therefore offers both a new lacrimal plug inserter with
distinct advantages over traditional instruments and offers a new
process that is significantly more efficient in terms of at least
time duration (by minimizing practitioner movements) and average
cost (by minimizing the dropping and loss of plugs and minimizing
total procedure time.) Other objects and advantages are detailed
forthwith in the remainder of the specification while still other
objects and advantages will be obvious to those skilled in the art
of lacrimal occlusion, trichiasis and other medical procedures.
BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS
[0011] The novel features of the invention are set forth with
particularity in the appended claims. The invention itself,
however, both as to organization and methods of operation, together
with further objects and advantages thereof, may best be understood
by reference to the following description, taken in conjunction
with the accompanying drawings in which:
[0012] FIG. 1 is a perspective drawing of a novel medical
instrument 10 comprising bull-dog style crossing arms 2 and 4
substantially for engaging, disengaging and otherwise manipulating
a plug such as 60 or 62 used in a lacrimal occlusion medical
procedure. Attached to arms 2 and 4 is dilator 50 such that tool 10
is easily manipulated by a practitioner between a dilator
instrument and a plug grasping and insertion instrument.
[0013] FIG. 2 is a flow chart describing the steps involved with a
traditional lacrimal occlusion process 100 that relies upon the use
of three distinct tools including a sizer instrument, a dilator
instrument and a thumb forceps instrument.
[0014] FIG. 3 is a flow chart describing the steps involved with
the lacrimal occlusion process 200 according to the present
invention that relies upon two distinct tools including a sizer
instrument and the present medical instrument 10 as depicted in
FIG. 1, where instrument 10 provides for both the functions of
punctal dilation and plug engagement, insertion and
disengagement.
[0015] FIG. 4A is a perspective drawing of medical instrument 10
where base 10a has been further adapted to accept a detachable
dilator 50 (not depicted) or a sizer-dilator 51 (depicted).
Sizer-dilator 51 provides both the dilator function of dilator 50
along with the sizer function traditionally provided by a separate
punctal-sizer instrument, thereby allowing further adapted
instrument 10 to provide all three traditional lacrimal occlusion
functions of: 1) sizing the punctum; 2) dilating the punctum, and
3) inserting a plug into the punctum in a single convenient tool.
Sizer-dilator 51 further includes various markings 51-m1, 51-m2,
51-m3 and 51-m4 covering the sizer profile 51-p1, where the various
markings are usable for determining the appropriate plug size for
selecting between plugs such as 60-1, 60-2, 60-3 and 60-4 of at
least differing diameters.
[0016] FIG. 4B shows a reference art drawing illustrating the use
of three different dimensioned punctal sizers to best determine the
size of a patient's punctum. Also depicted in an alternative sizer
profile 51-p2 for use with sizer-dilator 51, where alternative
profile 51-p2 is based upon the combination of at least two of the
reference art punctal sizer shapes, and where the profile 51-p2
preferably includes an optional dilator tip 51-t.
[0017] FIG. 5 is a flow chart describing the steps involved with
the lacrimal occlusion process 300 according to the present
invention, where process 300 relies upon the use of only one
distinct tool that is the present medical instrument 10 such as
depicted in FIG. 4 including sizer-dilator 51 as opposed to the
dilator 50 shown in FIG. 1. Instrument 10 that has been further
adapted to include sizer-dilator 51 provides for all of the
functions of process 300 including punctal sizing, punctum dilation
and plug engagement, insertion and disengagement.
[0018] FIG. 6A depicts eight various types of thumb forceps known
in the art, and more specifically depicts different forms of distal
ends (herein also called tips) found to be useful for either the
lacrimal occlusion procedure, such as the "angled-tip plug
insertion(API)" tip, or other various medical procedures such as
"cilia" tip for performing trichiasis, where any of these same or
similar tips, or indeed any of the many distal ends known in the
art, may be incorporated with the present invention.
[0019] FIG. 6B is a perspective drawing of medical instrument 10
where holding surface 10d has been further adapted to comprise
bases 48-base and 28-base for accepting a detachable distal end tip
48-tip1 and 28-tip1, respectively, where for example tips 48-tip1
and 28-tip1 are in the form of cilia style distal ends used for
trichiasis, or alternatively of any shapes herein described or
otherwise known in the reference art such as depicted in FIG.
6A.
[0020] FIG. 6C is a second view of the perspective drawing of
medical instrument 10 further adapted to accept a detachable distal
end tip 48-tip1 as shown in FIG. 6B, where the present figure
depicts the detachable distal end 48-tip1 including key 48-tip1-k
in a detached and orthogonal rotation prior to insertion into lock
48-base-l of distal end base 48-base.
[0021] FIG. 6D is a perspective drawing of the distal end of
instrument 10, where distal end 48a and 28a have been further
adapted to include latches 48a-l and 28a-l, respectively, for
securing tip sleeves 49a and 29a, respectively, and where sleeves
49a and 29a further include interior latches (not depicted) for
engaging latches 48a-l and 28a-l and exterior latches 49a-l and
29a-l for engaging a tray (see FIG. 6E).
[0022] FIG. 6E is a perspective drawing of sleeve box 70,
comprising sleeve trays 49a-t and 29a-t for receiving, holding and
discharging any of sleeves 49a and 29a, respectively. Each tray
49a-t and 29a-t such as 49a-t preferably further comprises a first
tray cavity 49a-tc1 for holding the non-tip portion of a sleeve
such as 49a, a second tray cavity 49a-tc2 for holding the tip
portion of a sleeve such as 49a, an interior latch 49a-tl for
impeding the lateral exit motion of a sleeve such as 49a and a
lateral tray entrance 49a-te for receiving a distal end of
instrument 10 such as 48a being inserted into a sleeve such as 49a
held within tray 29a-t.
[0023] FIG. 6F is a perspective view of instrument 10 further
adapted as described in FIG. 6D to comprise distal ends 48a and 28a
partially inserted into sleeves 49a and 29a, respectively, where
sleeves 49a and 29a are being held within trays 49a-t and 29a-t,
respectively, comprising sleeve box 70 as described in FIG. 6E.
[0024] FIG. 6G is a side view diagram depicting three steps 1, 2
and 3 for first inserting (steps 1 and 2) via substantially a
lateral motion distal ends such as 48a comprising latch 48a-l into
sleeves such as 49a held within sleeve box 70, and second removing
(step 3) via substantially a perpendicular motion sleeves such as
49a now secured via an interior latch (not depicted) to a distal
end latch such as 48a-l, where in the perpendicular motion exterior
latch 49a-l of sleeve 49a is substantially unimpeded by tray box
70. Whereas steps 1, 2 and 3 allow for the engagement and removal
of sleeves such as 49a from the tray box 70 by instrument 10, a
reversal of steps 1, 2 and 3 further allow for the replacement and
disengagement of sleeves such as 49a from tray box 70 by instrument
10, wherein during the reversal of step 3 tray box 70 substantially
impedes the removal of a sleeve such as 49a by catching exterior
latch 49a-l during the extracting lateral motion, thereby
disengaging a sleeve such as 49a from a distal end such as 48a.
[0025] FIG. 6H is a side-perspective view of a tray rack 72 for
example comprising three tray boxes 70-1, 70-2 and 70-3, where
instrument 10 is depicted as removing (or replacing) sleeves from
tray box 70-1 in accordance with the steps 1, 2 and 3 described
FIG. 6G.
[0026] FIG. 7A and 7B depict the distal end 48 of presently taught
medical instrument 10 that has been further adapted as distal end
48b comprising a screw type clamp-limiting means including knob
48b-k for turning by the practitioner, where turning the knob 48b-k
causes screw 48b-s to raise or lower commensurately into the
holding space between distal ends 48b and 28, thereby
proportionately effecting the tip gap and associated closing
(positive) pressure of instrument 10. Also depicted are markings
48b-m for indicating the direction and amount of turning of knob
48b-k that corresponds to desired plug sizes as prior determined
using a sizer-dilator with associated markings on profile 51-p1
(see FIG. 4A).
[0027] FIGS. 8A and 8B depict the distal end 48 of presently taught
medical instrument 10 that has been further adapted as distal end
48c comprising a sliding wedge type clamp-limiting means including
knob 48c-k for pushing forwards and backwards by the practitioner,
where pushing the knob 48c-k causes wedge 48b-w to slide
commensurately forwards or backwards into the holding space between
distal ends 48c and 28, thereby proportionately effecting the tip
gap and associated closing (positive) pressure of instrument
10.
[0028] FIGS. 9A and 9B depict the distal end 48 of presently taught
medical instrument 10 that has been further adapted as distal end
48d comprising a rotating oblong wheel type clamp-limiting means
including knob 48d-k for turning by the practitioner, where turning
the knob 48d-k causes oblong wheel 48d-w to rotate commensurately
into the holding space between distal ends 48d and 28, thereby
proportionately effecting the tip gap and associated closing
(positive) pressure of instrument 10.
[0029] FIGS. 10A and 10B depict the wide portions 24 and 44 of
presently taught medical instrument 10 that have been further
adapted as wide portions 24e and 44e comprising a rachet type
clamp-limiting means including pivoting rachet arm 44e-r in
combination with return pressure spring 24e-s, where, as the
practitioner applies normal opening pressure upon wide portions 24e
and 44e rachet combination 44e-r and 24e-s causes the wide portions
24e and 44e to essentially remain fixed at the closest separation
of portions 24e and 44e obtained prior to the release of the
opening pressure by the practitioner, thereby inverse
proportionately effecting the tip gap and associated closing
(positive) pressure of instrument 10.
[0030] FIGS. 11A and 11B depict the distal ends 28 and 48 of the
further adapted medical instrument 10 including a rachet type clamp
limiter as taught in relation to FIGS. 10A and 10B, to be further
adapted as tissue separating style distal ends 28t-2 and 48t-2.
DETAILED DESCRIPTION OF THE INVENTION
[0031] Referring to FIG. 1, there is shown a perspective view of a
first embodiment of medical instrument 10 that resembles a surgical
(or "bulldog") forceps well-known in the medical art for the
occlusion of blood vessels. Instrument 10 is about 60 mm long,
although the length may vary, and comprises a first arm 2 and a
second arm 4. First arm 2 is an elongated member made of a metal
such as stainless steel or a rigid, medical grade plastic. Starting
from the proximal end, the first arm 2 comprises a proximal portion
22, a wide portion 24 angled outwardly from the proximal portion, a
narrow portion 26 angled inwardly from the wide portion 22, and a
distal portion 28 angled outwardly from the narrow portion 26. The
second arm 4 is like the first arm 2, comprising a proximal portion
42, a wide portion 44 angled outwardly from the proximal portion
42, a narrow portion 46 angled inwardly from the wide portion 44,
and a distal portion 48 angled outwardly from the narrow portion
46. Proximal portions 22 and 42 are joined to one another, the
combination of which form the base 10a. Wide portions 22 and 42 are
detached from one another, the combination of which form a grasping
surface 10b whereupon a practitioner preferably maintains hold of
and operates instrument 10. It is preferred that at least the outer
grasping surfaces of wide portions 24 and 44 include surface
changes for increasing grip, such as a series of etched groves as
depicted in the present figure with respect to portion 44. Narrow
portions 26 and 46 are detached from one another, the combination
of which form the inflection point 10c. Distal portions 28 and 48
are detached from one another and movable such that in a normal
resting state portions 28 and 48 are touching while in an opening
state portions 28 and 48 are separated by some distance, where the
combination of distal portions 28 and 48 form the holding surface
10d for engaging and disengaging a plug such as 60 or 62. The
present invention anticipates that at least the touching (and
facing) surfaces of distal portions 28 and 48 can be any of smooth,
rough, serrated or even hollowed shaped to best grasp a particular
plug such as 60 or 62, and that preferably the combined closed tip
ends of portions 28 and 48 form a sharp point, but can also form a
blunt point.
[0032] Still referring to FIG. 1, as will be well understood by
those familiar with the treatment of dry eye using lacrimal (or
punctal) occlusion, there are many types of plugs for use in this
procedure including for example intracanalicular plugs such as 60
without a flange and punctal plug 62 including a flange, where such
plugs 60 and 62 come in various sizes, shapes and material com
positions.
[0033] As will be understood by those familiar with bulldog
forceps, a practitioner applies three distinct types of pressure to
properly operate the instrument 10, including what is herein
referred to as a handling pressure, an opening pressure and a
closing pressure (where a closing pressure is actually the relaxing
of the opening pressure). Using handling pressure, the practitioner
is able to pick up, move about and put down the instrument 10
without causing any relative changes in the distance between the
distal ends 28 and 48 of holding surface 10d. Hence, if the distal
ends 28 and 48 are not already engaging a plug such as 60 or 62,
then the ends 28 and 48 are touching and remain touching given only
handling pressure. If the distal ends 28 and 48 are already
engaging a plug such as 60 or 62, then the ends 28 and 48 are
substantially separated by some distance as dictated by the size,
shape and material composition of the plug 60 or 62 and the
location in which the plug was engaged, and this separation
distance remains substantially unchanged given only handling
pressure. It is important to see that once a plug such as 60 or 62
is engaged by the practitioner using the holding surface 10d of
instrument 10, there is only a minimum handling pressure required
by the practitioner to then move about the plug 60 or 62 as is
necessary for preforming the lacrimal occlusion procedure, where
this minimum handling pressure does not further include any of
opening or closing pressure.
[0034] Still referring to FIG. 1, in a typical use case, prior to a
plug being engaged, a practitioner grasps instrument 10 for example
placing their thumb somewhere on the wide portion 24 and their
pointer finger somewhere on the wide portion 44, essentially
encompassing grasping surface 10b. While in this plug-unengaged
state of instrument 10, distal portion 28 is in contact with distal
portion 48. When the practitioner the presses their grasping thumb
and pointer finger's together to apply an opening pressure, wide
portions 24 and 44 are brought together, and due to the crossing
arrangement of narrow portions 26 and 46 forming inflection point
10c, distal portions 28 and 48 are thereby separated and no longer
in contact. In a normal operation, while applying this opening
pressure, the practitioner moves the distal ends 28 and 48 to
surround some portion of a plug such as 60 or 62 and then applies a
closing pressure by relaxing the opening pressure, thus causing
distal ends 28 and 48 to engage the plug in some selected location.
The practitioner is then free to move the plug such as 60 or 62
about as necessary without the additional strain of maintaining a
closing pressure to secure the engaged plug, which is required when
using the traditional thumb forceps for engaging a plug such as 60
or 62.
[0035] Still referring to FIG. 1, there is also shown separator 52
located preferably along an inside edge of either wide portion 44
(as depicted) or wide portion 24 (not depicted). The function of
separator 52 is to limit the minimum separation distance between
wide portions 24 and 44 as caused by the application of opening
pressure by the practitioner. This limit is set to both allow
sufficient separation distances between distal ends 28 and 48 to be
achieved for engaging and disengaging plugs such as 60 and 62 while
also disallowing a maximum opening pressure that might for example
cause wide portions 24 and 48 to come into contact causing harmful
strain on arms 2 and 4 or even breaking instrument 10. As will be
obvious to those skilled in the art of instrumentation
manufacturing, there are many possible locations for placing
separator 52, and many shapes and sizes for separator 52, and even
other means for accomplishing the same function. It is even
possible to use multiple separators 52, for example each aligned to
oppose each other thus essentially equally splitting the minimum
limit. What is important to see is that preferably, but not
necessarily, some adaptation is added to instrument 10 to function
as a means for limiting the minimum separation distance between
wide portions 24 and 44 as caused by the application of opening
pressure by the practitioner.
[0036] Still referring to FIG. 1, instrument 10 preferably also
includes a dilator 50 attached to the base 10a of instrument 10
such that the dilator 50 points in the opposite direction of distal
portions 28 and 48, thus providing instrument 10 with a
dual-function of both dilating a patient's punctum with dilator 50
and engaging and disengaging a plug such as 60 or 62 with distal
portions 28 and 48. The preferred shape of the dilator 50 is wider
at the point of attachment to the base 10a, tapering off to form a
point at the functioning end. In the preferred arrangement, dilator
50 is permanently attached to the base 10a. However, it is further
anticipated that the dilator 50 can be detachable from the base
10a, for example where dilator 50 includes a threaded screw (or
"key and lock", see upcoming FIG. 4A) and therefor can be screwed
into an appropriately sized threaded opening in the base 10a. Using
this detachable dilator 50 alternate embodiment of instrument 10,
it is then possible to allow instrument 10 to further adapt to
different sized dilators 50 and even to further adapt to other
types of tools for use in combination with the clamping arms 2 and
4. The present invention anticipates that the functioning tip end
of dilator 50 can be sharp or blunt, or have various other shapes
and designs commonly utilized within the ophthalmology industry,
where for example the detachable dilator 50 can vary in any of
these features.
[0037] And finally, in the lower right-hand corner of FIG. 1,
juxtaposed with exemplary plugs 60 and 61 there is depicted an
exemplary end tip adaptation referred to as plug receptacle 48a. In
one possible operation of instrument 10, after the practitioner
uses distal ends 48 and 28 (in any tip configuration, for example
see upcoming FIG. 6) to first engage a plug, second partially
insert the plug, and third disengage the plug, the practitioner
then uses the plug receptacle 48a as a means for better
manipulating the plug for further insertion into the punctum, where
better manipulating includes receiving the end of the plug
currently protruding from the punctum into the concavity of
receptacle 48a, such that once received the practitioner is better
able to guide and apply directional pressure upon the plug for
insertion into the punctum.
[0038] As will be clear based upon a careful consideration of the
purposes of plug receptacle 48a, especially to those familiar with
medical instruments and the lacrimal occlusion procedure, there are
many possible forms and arrangement for plug receptacle 48a and
thus the present depiction should be considered as exemplary,
rather than as a limitation of the present invention. For example,
plug receptacle 48a as currently depicted with a concavity parallel
to the grasping and therefore plug insertion axis, could
alternately be rotated for example 90 degrees to be perpendicular
with the direction of plug insertion. Additionally, and
alternatively, the plug receptacle 48a could be a of different
size, shape or attached location while still providing for the
essential means of receiving the plug to improve the practitioner's
control during the insertion process. And finally, with respect to
variations of plug receptacle 48a, it is even possible that the
receptacle 48a is divided into two left-right partitions, centered
with respect to each other and located between the tips 48 and 28,
where for example the "left half" of divided receptacle 48a
(comprising essentially half of 48a) is comprised within the tip of
distal end 48 and where essentially the remaining "right half" of
48a is comprised within the tip of distal end 28, such that after
disengaging a plug and due to the inherent positive pressure of
instrument 10 the two distal ends 48 and 28 are in contact and
collectively form the receptible 48a by bringing the left and right
halves of divided alternate receptacle 48a together between the
tips for a similar usefulness of receiving and more easily guiding
the a plug.
[0039] Referring next to FIG. 2, there is shown a flow diagram
describing the basic steps for performing the lacrimal occlusion
process 100 as currently and commonly practiced in the art. First,
it should be noted that the current process 100 requires three
distinct tools, namely: 1) a first sizer instrument for measuring
the size of the patient's punctum into which a plug such as 60 or
62 is to be inserted, sometimes referred to as a punctal sizing
gauge; 2) a second dilator instrument for inserting into the
punctum to cause the opening to enlarge in preparation for
receiving the plug, and 3) a third thumb forceps instrument for
grasping and holding a plug such as 60 or 62 using a continuous
closing pressure while attempting to insert the plug into the
punctum.
[0040] Still referring to FIG. 2, in a first step 101, the
practitioner uses one or more sizer instruments to probe and
estimate the size of the patient's punctum, for example determining
that the punctum size is 0.6 mm. In step 102, the practitioner
decides if the punctum should first be dilated prior to attempting
to insert a plug such as 60 or 62. If the decision is "no," the
practitioner proceeds to step 104, and otherwise if "yes" then
performs step 103 using a separate dilator instrument to apply
pressure on the punctum slightly enlarging its orifice. Next, in
step 104 the practitioner selects an appropriate plug such as 60 or
62 based upon the chosen medical procedure (for example an
intracanalicular plug such as 60 without a flange for inserting
through the punctum into the interior of the lacrimal duct
(canaliculus), and punctal plug 62 for partially inserting into the
canaliculus such that the flange is still protruding from the
puncta, all as is well known in the art). In step 105, the
practitioner uses a traditional thumb forceps instrument that is in
an open position in the resting state (i.e. without external
closing pressure being applied by the practitioner), to first
surround and then grasp the selected plug, where grasping means
that the practitioner applies a closing pressure on the arms of the
thumb forceps in order to cause the distal ends of the forceps'
arms to close and engage the plug.
[0041] Continuing with step 106, the practitioner then attempts to
insert plug such as 60 or 62 into the punctum. It is important to
note the following difficulties with this step: 1) the step is
performed around the patient's eye which is both uncomfortable for
the patient and puts the patient at some risk, therefore the step
duration is ideally limited; 2) both the punctum and the plug are
small requiring precise movements from the practitioner; 3) the
practitioner is required to maintain a sufficient closing pressure
for continuing to secure the plug with the thumb forceps while at
the same time moving their hand to direct the plug into the
punctum, where this combination of exertion is delicate increasing
the likelihood of either dropping the plug or having the plug slip
in its initial position with respect to the grasping forceps (thus
needing to be set down and repositioned delaying the total step
time), and 4) the plugs such as 60 or 62 are easily dropped (for
example by releasing closing pressure during step 106) or damaged
(for example by applying too much closing pressure during step
106), which is costly as a typical plugs range in price from $50 to
over $250 each.
[0042] Still referring to FIG. 2, at some point in step 106 the
practitioner will decide as step 107 if the plug is fitting through
the punctum. If "yes," this fitting results in at least a partial
insertion of the plug through the punctum into the canaliculus such
that the practitioner in step 108 is then able to release closing
pressure disengaging the plug from the distal end of the thumb
forceps to remain at least partially inserted through the punctum.
In final step 109, the practitioner then typically uses the distal
end of one of the forceps' arms to further push the plug into the
canaliculus but still protruding from the punctum (e.g. if a
punctal plug 62), or all the way into the canaliculus and not still
protruding from the punctum (e.g. if an intracanalicular plug 60),
where full insertion often requires the practitioner to switch from
using the forceps to using the dilator instrument since the dilator
has a single narrowed and elongated point that is ideal for pushing
the plug deeper into the canaliculus, and where then this switching
has the negative effects of both drawing the attention of the
practitioner away from the patient's punctum and further increasing
the duration of the process.
[0043] It should be noted that the distal end of one of the arms of
the forceps is not an ideal tool for pushing the plug further into
the punctum, for example as compared to a single ended tool such as
a dilator instrument, where the pointed end of the dilator can be
better used to push the plug. In a careful consideration, one of
the problems with using the thumb forceps to further push the plug
is that while the distal end of one arm is being used to push upon
the plug, the distal end of the opposing arm is free and separated
presenting itself closer to the patient's eye depending upon the
motions chosen by the practitioner. In any case, it is not ideal
that the practitioner take their eyes off the plug or otherwise
divert their attention during the continuous performance of steps
106 through 109, (during which for example the patient could blink
or in some way cause the plug to dislodge and therefore requiring a
restart with a new plug). Since the practitioner is required to
maintain their focus on the plug and since the practitioner
typically does not have an assistant to which they could hand the
thumb forceps and request a different tool such as the dilator
instrument, the practitioner is forced to continue the fitting in
step 109 using the thumb forceps.
[0044] Referring still to FIG. 2, if the practitioner decides that
the plug is not fitting, i.e. "no," in step 107, then rather than
proceed to step 108 the process continues to step 110. In step 110,
regardless of the reason that the plug such as 60 or 62 is not
fitting, the practitioner is forced to disengage the plug from the
thumb forceps to be set down preferably on a sterile surface. This
disengagement is caused by the practitioner relaxing their
continuous closing pressure being applied in step 106, thus
resulting in opening pressure that causes the distal ends of the
forceps to separate, thus dropping (i.e. disengaging) the plug. In
step 111, the two main reasons why the decision of step 107 is "no"
are: 1) a different sized plug is needed, or 2) the punctum orifice
should be further expanded using a dilator. Both situations are
common, but it is most often the case that the practitioner simply
needs to further dilate the punctum (i.e. returning to step 103).
As a careful consideration will show, since the practitioner must
maintain a closing pressure on the plug using the thumb forceps, it
is not possible to keep the plug engaged by the forceps before
returning to step 103, this is even true if the forceps where
further adapted to include an attached dilator. Hence again, if in
step 107 the practitioner decides "no" that the plug is not fitting
for any reason, it is always necessary to perform step 110, i.e.
disengaging the plug from the thumb forceps where this step only
further unfavorably delays the entire process and increases the
risk of dropping or damaging the plug.
[0045] Assuming the most common case that the reason the plug is
not fitting is that the punctum needs further dilation, it will
then be shown in upcoming FIG. 3 a distinct advantage of the
presently described medical instrument 10. In this most common
case, using the traditional thumb forceps, the practitioner must:
1) disengage the plug and set down the thumb forceps (step 110), 2)
pick up the dilator tool and further dilate the punctum (step 103),
3) set down the dilator tool and then re-select (at least requiring
a refocusing of vision and attention) the plug for reinsertion
(step 104), and then must 4) pick up the thumb forceps and reengage
the selected plug. As will be shown with respect to upcoming FIG.
3, in the most common case of needing further dilation in response
to steps 107 and 111, the present invention avoids: 1) step 110 of
disengaging the plug followed by setting down the thumb forceps; 2)
picking up a separate dilator tool to perform step 103 which draws
the practitioner's gaze away from the patient's punctum (as opposed
to flipping the medical instrument 10 in the practitioner's hand to
present the dilator 50 as the functioning end of the instrument 10
while at the same time the practitioner continues to focus their
gaze on the punctum); 3) setting down the separate dilator tool in
order to pick up the thumb forceps to perform step 105 which draws
the practitioner's gaze away from the punctum (as opposed to
flipping the medical instrument 10 in practitioner's hands to
present the distal ends 28 and 48 still engaging the plug as the
functioning end of the instrument 10 while at the same time the
practitioner continues to focus their gaze on the punctum), and 4)
re-focusing on (i.e. selecting) the plug in step 105 and applying
closing pressure on the thumb forceps to re-engage the plug which
further draws the practitioner's gaze away from the punctum and
delays the medical procedure (again, as opposed to flipping the
medical instrument 10 in practitioner's hands to present the distal
ends 28 and 48 still engaging the plug as the functioning end of
the instrument 10 while at the same time the practitioner continues
to focus their gaze on the punctum).
[0046] Still referring to FIG. 2 and the process of the prior art
implemented using thumb forceps, at least steps 106 and 110 are
especially problematic, and then also steps 103, 105 and 109 are
non-ideal.
[0047] Referring next to FIG. 3, there is shown a flow diagram
describing the basic steps for performing the lacrimal occlusion
process 200 using the preferred and herein taught medical
instrument 10. As with traditional process 100, in the preferred
process 200 steps 101 and 102 are first performed by the
practitioner for determining both the size of the patient's punctum
(step 101) and deciding if the punctum should be dilated (step
102). If it is decided that the punctum does not require dilation,
the practitioner then proceeds to step 104, which is the same as in
process 100. If it is decided that the punctum does require
dilation, then in step 203 the practitioner selects new medical
instrument 10 (rather than a separate dilator) and orients the
instrument 10 such that the dilator 50 end is the functioning end
(i.e. currently pointing outward/away from the practitioner's hands
and body for use on the patient). After picking up instrument 10,
the practitioner dilates the patient's punctum using dilator 50
attached to instrument 10.
[0048] Still referring to FIG. 3, and now proceeding from step 203
to step 104, the practitioner then selects the appropriately sized
plug such as 60 or 62 by scanning with their eyes to find the
plug's location and to confirm the plug's type and size. Once
located and confirmed in step 104 (that is substantially like step
104 in process 100), unlike step 105 in process 100, the
practitioner performs a simplified step 205 in process 200.
Specifically, since the practitioner is already holding instrument
10 (for using the dilator 50 in step 203), the practitioner then
continues to maintain a grasp of instrument 10 rotating the
instrument 10 such that the distal ends 28 and 48 are now the
functioning end, after which the practitioner applies opening
pressure to arms 2 and 4 of instrument 10 to separate distal ends
28 and 48 for surrounding and engaging the selected plug such as 60
or 62, where a careful consideration will show that after
surrounding the plug the practitioner relaxes the opening pressure
(thus applying closing pressure) that allows the distal ends 28 and
48 to engage the plug using the positive pressure inherent in the
proper construction of instrument 10 (that is typically a spring
tension as implied in the depiction of instrument 10 in FIG. 1,
although many solutions are available as will be well known to
those familiar with bulldog forceps).
[0049] Proceeding now to step 206, there is another substantial
difference to be considered between the present invention and the
prior art. In step 206, as opposed to process 100 step 106, the
practitioner does not need to apply any closing pressure because
this closing pressure is being provided by the instrument 10.
Instead, the practitioner is free to use handling pressure alone to
manipulate the instrument 10 and thereby the plug such as 60 or 62,
guiding and directing it into the patient's punctum. As will be
clear upon a careful consideration, in process 100 the physical
effort of maintaining a sufficient but not excessive closing
pressure on the plug using thumb forceps, while then also moving
the hand to adjust the plug's location, is significantly more
complex than the presently described step 206 and often exacerbates
the unwanted shaking of the practitioner's hand which further
places the patient at risk. As prior discussed, this present
instrument 10 and process 200 have many benefits including: 1)
reducing any likelihood that the plug is dropped, where dropped
plugs cost significant money; 2) decreasing the muscle movement
complexity required by the practitioner thus reducing mental stress
and physical handing shaking; 3) enhancing the efficiency of the
procedure as the practitioner is no longer concerned with dropping
the plug and can move the instrument 10 with greater ease, where
the increased efficiency results in a minimum of process duration
for the patient thus reducing the patient's mental stress, and 4)
decreasing the likelihood of inadvertently touching and possibly
hurting the patient's eye due to the need to manage a greater
volume of space created by the separated distal ends of normal
resting state thumb forceps as compared to the lesser volume of
space created by the touching distal ends 28 and 48 of normal
resting state instrument 10 (see step 209). Other benefits will be
clear to those familiar with the lacrimal occlusion procedure.
[0050] Still referring to FIG. 3, after achieving at least partial
insertion of the plug such as 60 or 62 into the patient's punctum,
like process 100, the practitioner decides in step 107 if the plug
is fitting. If the answer is "yes," then in step 208 the
practitioner applies opening pressure to separate the distal ends
28 and 48 of instrument 10 in order to disengage the plug. After
disengaging the plug, the practitioner then relaxes the opening
pressure (thus applying closing pressure) to the cause the distal
ends 28 and 48 to return to a resting, disengaging and touching
position. The careful reader will note the advantages that distal
ends 28 and 48 of instrument 10 are touching (thus taking up less
volume) as opposed to the distal ends of a traditional thumb
forceps that are separated while in the resting and disengaged
state (thus taking up more volume). As prior mentioned, the total
volume encompassed by the touching distal ends 28 and 48 of
instrument 10 are less than the total volume encompassed by the
distal ends of traditional thumb forceps, thus creating a safer
tool for use near the patient's eye and also making it easier for
the practitioner to adjust the instrument 10 for prodding the plug,
pushing it further into the punctum as dictated by the chosen
medical procedure.
[0051] If the answer to step 107 (is the plug fitting) is "no,"
then unlike process 100 the practitioner is not required to always
disengage the plug but rather may first consider in step 210 if a
different sized plug is necessary. If a different plug is
necessary, then the practitioner completes step 212 and disengages
the plug by applying opening pressure. Once disengaged, the
practitioner is then free to proceed to step 104 to repeat process
200 from the point of selecting a plug. As those familiar with
lacrimal occlusion procedures will understand, it is more often the
case that the answer to step 210 (is a different sized plug needed)
is "no." In this case, the present invention offers another
significant benefit in that the practitioner is not required to: 1)
disengage the plug (process 100, step 110); 2) set down the thumb
forceps, and 3) pick up the separate dilator instrument all prior
to further dilating the patient's punctum (process 100, step 103).
Furthermore, as a careful comparison of process 200 versus 100 will
show, in process 100 after this second dilation (i.e. process 100,
step 103) the practitioner then must proceed to step 104 through
105 before again attempting to insert the plug in process 100 step
106, whereas in process 200, after completing step 203 the
practitioner is enabled to proceed directly to step 206 (i.e.
skipping steps 104 and 205 in favor of simply rotating instrument
10 to present the distal ends 28 and 48 still engaging the plug as
the functioning end of the instrument 10).
[0052] In summary of the present inventive step 211, the
practitioner keeps the instrument 10 in their hands while rotating
the instrument 10 such that the dilator 50 is the functioning end.
Once this simple rotation is made, the practitioner is free to
dilate the patient's punctum. After dilation, rather than having to
then set down a separate dilator instrument and proceed to a
process 100 step 104, 105, etc. using thumb forceps, the
practitioner simply rotates the distal ends 28 and 48 (currently
and still engaging the prior selected plug), such that the distal
ends are the functioning end of instrument 10. Once rotated, the
practitioner then proceeds to step 206 as prior described.
[0053] Referring now to both FIGS. 2 and 3, what is clear is that
the new instrument 10 and process 200 offer significant advantages
over traditional thumb forceps and a traditional thumb
forceps-based process 100. The use of new instrument 10 and process
200 have many benefits including: 1) reducing any likelihood that a
plug is dropped, where dropped plugs cost significant money; 2)
decreasing the muscle movement complexity required by the
practitioner thus reducing both mental stress and physical hand
shaking; 3) enhancing the efficiency of the procedure as the
practitioner is no longer concerned with dropping the plug and can
move the instrument 10 with greater ease, where the increased
efficiency results in a minimum of process time for the patient
thus reducing the patient's mental stress; 4) avoiding the need to
always disengage the plug, set down the thumb forceps, and pick up
a separate dilator instrument if all that is required during the
insertion process is a further dilation of the patient's punctum,
where after dilation the present invention then also avoids needing
to set down the separate dilator, pick up the thumb forceps, find
and re-engage the plug prior to continuing the insertion step, the
excessive combination of which distracts the practitioner's
attention from the patient and increases the duration of the
process and the patient's mental stress; 5) decreasing the
likelihood of inadvertently touching and possibly hurting the
patient's eye during adjustment step 209 due to the reduced volume
of space taken up by the touching distal ends 28 and 48 of
instrument 10 as compared to step 109 where the normally separated
distal ends of the thumb forceps create an increased volume making
their use as a prodding tool more difficult; and 6) providing the
practitioner a single instrument 10 choice between means for
prodding, pushing and adjusting the plug during step 209, where the
choice is to use the touching distal ends 28 and 48 or to rotate
instrument 10 and use the dilator 50, where the dilator 50 is
especially useful for pushing a intracanalicular plug such as 60
deeper into the canaliculus especially as opposed to using
separated thumb forceps distal ends. Other benefits will be clear
to those familiar with the lacrimal occlusion procedure, for
example, it is sometimes the case that after insertion the
practitioner decides it is necessary to remove the plug such as 60
or 62, in which a careful consideration will show that it is far
more efficient for the practitioner to remove the plug using
instrument 10 if just prior to this the same plug was being pushed
further into the punctum using a dilator therefore requiring a
switch back from the dilator to a grasping tool (such as thumb
forceps or the distal ends 28 and 48 of instrument 10).
[0054] Referring next to FIG. 4A, there is shown a perspective
drawing of medical instrument 10 where base 10a has been further
adapted to accept a detachable dilator 50 (not depicted) or a
sizer-dilator 51 (depicted). Sizer-dilator 51 provides both the
dilator function of dilator 50 along with the sizer function
traditionally provided by a separate medical instrument. In
particular, the distal end of sizer-dilator 51 includes a sizer
profile 51-p1 that is preferably an elongated conical shape
increasing continuously and smoothly in diameter starting at the
distal tip proceeding at least part way towards the base of
sizer-dilator 51, where the base of sizer-dilator 51 includes a
mechanism for attaching to the base 10a of instrument 10. While
those familiar with mechanical systems will recognize that many
possible mechanisms for attaching a detachable sizer-dilator 51 or
dilator 50 to base 10a are possible, for example a simple
screw/screw hole combination, the preferred detachable
sizer-dilator 51 (or detachable dilator 50) includes what is herein
referred to as a key/lock combination. In the present depiction,
the key 51-k comprises a "T" shaped member for inserting into a
similarly shaped lock 10a-l provided by instrument base 10a. Once
the key 51-k is inserted into lock 10a-l, the exemplary
sizer-dilator 51 is then rotated or twisted orthogonally with
respect to the longitudinal axis of instrument 10 such that the "T"
shaped member is then substantially rotated by 90 degrees from its
original insertion orientation.
[0055] Still referring to FIG. 4A, as will be clear to those
familiar with the lacrimal occlusion process, a sizer is
necessarily similar in diameter to a dilator, as both must
essentially fit into the patient's punctum. A traditional punctal
sizer is a cylindrical shape that is not increasing in diameter
starting at the distal end. Therefore, a traditional single punctal
sizer instrument typically includes two opposing ends, where the
first end includes a cylinder shape of a first diameter and the
second end includes a cylinder shape of a second diameter. Given
that the punctum sizes of typical patients range between at least
four different orifice diameters, such as 0.2 mm, 0.4 mm, 0.6 mm
and 0.8 mm, it is typically necessary for the practitioner to have
at least two and often three separate punctal sizer tools for use
when determining the size of the patient's punctum (see step 101 in
FIG. 2 and FIG. 3). As will be clear to those familiar with the
lacrimal occlusion process, having a single sizer tool, or a
removable sizer-dilator such as 51 comprising a sizer profile 51-p1
sufficient for distinguishing between two or more distinct sizes
offers significant advantage to be discussed further with respect
to upcoming FIG. 5. The depicted sizer profile 51-p1 of the present
figure with an elongated conical shape is more convenient and
efficient than working with multiple tools.
[0056] The preferable sizer, such as sizer-dilator 51, further
includes multiple size markings such as size 1 marking 51-m1, size
2 marking 51-m2, size 3 marking 51-m3 and size 4 marking 51-m4,
where for example the segment of the elongated conical shape marked
as 51-m1 has a maximum diameter of 0.2 mm, while the segment of the
elongated conical shape marked as 51-m2 has a maximum diameter of
0.4 mm, the segment of elongated conical shape marked as 51-m3 has
a maximum diameter of 0.6 mm, and the segment of elongated conical
shape marked as 51-m4 has a maximum diameter of 0.8 mm.
[0057] Still referring to FIG. 4A, in the anticipated use of
sizer-dilator 51 attached to instrument 10 base 10a, the
practitioner first inserts the sizer-dilator 51 (in step 301-303,
FIG. 5) into the patient's punctum, continuing to insert
sizer-dilator 51 up and until it is recognized that the
sizer-dilator 51 has substantially filled the orifice of the
punctum. Once reaching this substantially filled depth, the
practitioner determines preferably a color of the marked segment
such as 51-m1, 51-m2, 51-m3 or 51-m4 that is best representative of
the size of the punctum's orifice, where after the practitioner is
then able to select an appropriately sized plug such as 60-1, 60-2,
60-3 or 60-4, respectively. It is further anticipated that at least
some portion of the plugs such as 60-1, 60-2, 60-3 or 60-4 are also
color coded or marked in a matching scheme with the markings 51-m
of sizer-dilator 51.
[0058] Referring next to FIG. 4B, there is shown on the left a
reference art drawing for the traditional substantially
cylindrical, single size punctal-sizer instrument, where the
instrument is inserted into the patient's punctum to test the
"resistance" provided by the punctum to the substantially
cylindrical shape, where each shape is a different "gauge size".
The correct gauge size gives the correct resistance upon both
entering and exiting the punctum, where the resistance is
fundamentally a judgment made by the practitioner. As will be clear
to the careful observer, the combination of for example a small,
medium and large gauge size tools is a discontinuous measurement
system, whereas the profile 51-p1 described in FIG. 4A is a
continuous profile capable of determining sizes without resorting
to increments such as small, medium and large, and therefore
accommodates punctum sizes that are essentially in between for
example small and medium, or medium and large.
[0059] Still referring to FIG. 4B, to the right of the reference
art drawing there is shown an alternative sizer-profile 51-p2 for
use with the sizer-dilator 51 (or even a non-detachable version of
sizer-dilator 51). Rather than providing an elongated conical shape
continuously and smoothing increasing in diameter starting at the
distal tip proceeding at least part way towards the base of
sizer-dilator 51 as depicted in FIG. 4A, the sizer-profile 51-m2
commences on the far distal end with an optional dilator tip 51-t,
followed by at least one and preferably at least two distinct
substantially cylindrical shaped profiles, for example
substantially similar to the profiles shown in the reference art
drawing of the present figure such as small, medium and large. The
present invention further anticipates providing for a traditional
separate sizer tool that includes two or more different gauge sizes
on a single end of the tool. Those familiar with the lacrimal
occlusion process will recognize the benefit of using a traditional
separate sizer instrument that has been so adapted to have a
profile including at least two gauge sizes (such as presently
depicted as profile 51-p2) as this increases the efficiency of the
practitioner whereby choosing for example a further adapted
separate traditional sizer tool that includes the sizes small and
medium on one end of the instrument and medium and large on the
other end at least reduces the number of separate sizer tools thus
making the overall procedure more efficient.
[0060] Based upon a careful consideration of the teachings
presented herein, especially those familiar with the lacrimal
occlusion procedure and furthermore with traditional sizer
instruments for use in determining the size of the patient's
punctum will recognize that multiple various profiles such as 51-p1
or 51-p2 are possible without departing from the spirit of the
invention, and as such the present depictions of sizer profiles
51-p1 and 51-p2 should be considered as exemplary, rather than as
limitations of the present invention.
[0061] Referring next to FIG. 5, there is shown a flow diagram
describing the basic steps for performing the lacrimal occlusion
process 300 using the preferred and herein taught medical
instrument 10 that has been further adapted to use a sizer-dilator
51 (depicted in FIGS. 4A and 4B) as opposed to dilator 50 (depicted
in FIG. 1). A careful comparison with process 200 depicted in FIG.
3 will show the following differences between process 300 and
process 200. The major difference is that steps 101 (using sizer
instrument, determine size of punctum), 102 (should punctum be
dilated) and 103 (using dilator 50 on instrument 10, dilate
punctum) have been replaced by a single step 301-303.
[0062] This is referred to as a single step (301-303) because it is
accomplished using a single further adapted instrument 10, rather
than a separate traditional punctal sizer and an instrument 10 as
described for use in process 200. To further highlight the benefit
of providing a single instrument 10 capable of providing both the
punctal sizing and punctal dilation functions, it should be
understood that in traditional practice there is not one punctual
sizer tool but often at least a set of three separate punctal
sizers, where each punctual sizer in the set accommodates two
distinct sizes, one size on each of the instrument's end points. By
providing a single sizer-dilator 51 on instrument 10 with a
continuous profile such as 51-p1 it is now possible to cover at
least two or more punctal sizes with a single detachable
sizer-dilator 51. In an ideal situation the continuous profile
51-p1 is usable to determine the entire range of punctal sizes
(e.g. 0.2 mm through 0.8 mm) and as such a single instrument 10 is
further adapted to include such an ideal profile sizer-dilator 51
as either a detachable sizer-dilator 51 using a key-and-lock (as
depicted in FIG. 4A) or alternative detachable mechanism or a
permanently affixed sizer-dilator 51 (similar to dilator 50 as
depicted in FIG. 1.)
[0063] Still referring to FIG. 5, if an ideal sizer-dilator 51
profile is used, then step 301-303 is accomplished with a single
tool 10 as taught herein, where the practitioner commences the
process 300 in step 301-303 by solely using the further adapted
instrument 10 including a sizer-dilator such as 51 with a single
ideal profile. In a variation of process 300, it is also possible
that the entire range of possible punctum sizes is divided into N
ranges, where a range N includes at least 2 of the traditional
sizes, such as small and medium, or 0.4 mm and 0.6 mm. Each of the
N ranges therefore preferably includes a unique sizer-dilator 51
with a profile such as 51-p1 or 51-p2 covering the traditional
sizes of that range. Each of these unique sizer-dilators 51 is then
preferably in a detachable form (such as the key-lock form depicted
in FIG. 4A) such that in a first step 301 (i.e. rather than a
combined step 301-303) the practitioner makes a visual judgment and
selects the anticipated best detachable sizer-dilator 51 for
attaching to instrument 10 as a part of performing a separate step
301. If the visual judgment selection is correct, then the
practitioner is able to both determine the punctal size and dilate
the punctum using the selected sizer-dilator 51 that has been
attached to instrument 10. If the visual judgement selection is
incorrect, then the practitioner disengages the first selected
sizer-dilator 51 in favor of a second selected sizer-dilator 51
accommodating different traditional sizes. As a careful
consideration will show, as the total number of ranges N decreases,
meaning that each range includes more possible punctal sizes, the
number of possible separate sizer-dilator 51 choices decreases,
where again, the ideal is a single range such that N=1 and covers
all sizes.
[0064] Referring still to FIG. 5, a careful consideration will show
that it is also possible that the N ranges are overlapping in size,
for example a first range covers sizes 0.2 mm-0.5 mm, a second
range covers sizes 0.4 mm-0.7 mm and a third range covers sizes 0.6
mm-0.9 mm. In such an arrangement, the practitioner's judgment call
is made simpler since for example the practitioner could consider
the first range to be "small", the second range to be "medium" and
the third range to be "large", where the presumption is that the
majority of the time the practitioner is then able to make a visual
examination of the patient's punctum and then properly select the
correct small, medium or large punctal sizer-dilator 51 thus
accomplishing step 301-303 using a single instrument 10. It should
also be noted that it is possible that the practitioner has in this
example 3 distinct instruments 10, each distinct instrument 10 with
a different small, medium or larger sizer-dilator 51 that is
permanently attached. Using three instruments then avoids the
requirement of selecting a detachable sizer-dilator and then
attaching the sizer-dilator 51 to the instrument 10 prior to use.
As will be understood by those familiar with the lacrimal occlusion
process, creating a combined instrument 10 that preforms all of the
sizer, dilator and plug insertion functions has significant
advantages and that of the many variations discussed herein, there
are different benefits to each variation. As will also be clear,
other variations are possible while still staying within the spirit
of a 3-in-1 lacrimal plug inserter.
[0065] And finally, still referring to FIG. 5, process 300 after
step 301-303 is substantially identical to process 200 with only
the small exception that process 200 step 211 (using dilator 50 on
instrument 10, dilate punctum) is replaced with process 300 step
311 (using sizer-dilator 51 on instrument 10, dilate punctum).
[0066] FIG. 6A depicts eight various types of thumb forceps known
in the art, and more specifically depicts different forms of distal
ends (herein also referred to as "tips") found to be useful for
either the lacrimal occlusion procedure or other various medical
procedures, where any of these same ends may be incorporated with
the present invention. Thus, as will be clear to those skilled in
the art, the present invention may be further adapted to include
other types of distal ends for example as found on traditional
thumb forceps whereby the other advantages of the present
instrument 10 are then combined with the advantages of the existing
art instrument distal ends. For example, the distal ends 28 and 48
of the present invention 10 as depicted and described in relation
to FIGS. 1 and 113 can alternately be implemented to look and
function substantially like what is referred to in the art as an
"angled-tip plug Insertion (API)" tip, whereby instrument 10 is
still intended for use in the lacrimal occlusion medical procedure.
Alternatively, the prior described distal ends 28 and 48 could be
implemented to look and function substantially like what is
referred to in the art as a "cilia" tip, whereby instrument 10 has
therein been further adapted for use in the medial procedure
referred to as trichiasis.
[0067] What is important to see is that there are many benefits
herein taught with respect to instrument 10, wherein these benefits
are not strictly relegated to the form of distal ends 28 and 48, as
many forms are possible and will be apparent to those skilled in
the art, especially with respect to the lacrimal occlusion
procedure, but also with respect to other medical procedures, and
even to non-medical procedures. Thus, in keeping with the spirit of
the invention, the various instrument 10 parts depicted herein such
as distal ends 28 and 48, proximal end dilator 50 or sizer-dilator
51, or even arms 2 and 4 should be considered as exemplary rather
than as limitations of the present invention. Those skilled in the
art of medical instruments will realize that each of the various
parts of instrument 10 described herein may be altered with respect
to form or material construction without departing from the
intentions and purposes of the respective parts, and therefore many
variations are anticipated.
[0068] Referring next to FIG. 6B, there is shown a perspective
drawing of medical instrument 10 that has been further adapted to
allow instrument 10 to function with an interchangeable range of
possible distal end tips, such as those depicted in FIG. 6A. In
reference to prior FIG. 1, holding surface 10d was taught to be
formed by the distal ends 28 and 48 of arms 2 and 4, respectively,
where in FIG. 1 distal ends 28 and 48 where non-detachable (i.e.
permanent). In the present FIG. 6B, distal end 28 of arm 2 has been
further adapted to include permanent base 28-base for receiving any
of detachable tips such as "cilia" style tip 28-tip1. Likewise,
distal end 48 of arm 4 has been further adapted to include
permanent base 48-base for receiving any of detachable tips such as
"cilia" style tip 48-tip1. As will be clear from a careful
consideration of the present figure and the teaching provided
herein, instrument 10 may be implemented with any combination of:
1) a permanent proximal end such as dilator 50 depicted in FIG. 1
or an interchangeable proximal end for receiving for example
detachable sizer-dilator 51 including any number of profiles such
as 51-p1 or 51-p2, and 2) a permanent distal end such as distal
ends 28 and 48 depicted in FIG. 1 or an interchangeable distal end
including bases 28-base and 48-base, respectively, for receiving
for example detachable cilia style tips 28-tip1 and 48-tip1,
respectively, or an adaptable distal end including latches for
receiving tip sleeves (see upcoming FIGS. 6D, 6E, 6F, 6G and
6H).
[0069] Referring next to FIG. 6C detachable distal tip 48-tip1 is
show as detached from distal base 48-base and furthermore rotated
orthongally with respect to the final attached position depicted in
FIG. 6B. Distal tip 48-tip1 is depicted as including an attaching
member such as key 48-tip1-k while distal base 48-base is depicted
as including a receiving member such as lock 48-base-l. This
"key-and-lock" system is preferably the same as prior described in
FIG. 4A in relation to detachable sizer-dilator 51 including key
51-k and instrument base 10a including lock 10a-l. As also prior
mentioned in relation to FIG. 4A, those familiar with mechanical
systems will recognize that there are many possible mechanisms for
attaching a detachable distal end tip such as 28-tip1 or 48-tip1 to
a base such as 28-base or 48-base, respectively, and as such the
present depiction should be considered as exemplary rather than as
a limitation of the present invention. It is even possible that the
key-lock mechanical systems depicted in both FIG. 4A and the
present FIG. 6C can be modified while still staying with the spirit
of a key and lock, where for example the shapes of the key such as
48-tip1-k and lock such as 48-base-l are modified in such a way
that the detachable tip such as 48-tip1 is limited to being
inserted into lock 48-base-l from only one of the two possible
(preferably, but not necessarily) orthogonal rotations.
Furthermore, the interior (not depicted) of a lock such as
48-base-l may be shaped in such a way that after insertion of a key
such as 48-tip1-k into lock 48-base-l, tip 48-tip1 may only be
rotated in a single direction, for example clockwise when viewed
from the distal end of instrument 10 looking towards the proximal
end of instrument 10, as presently depicted.
[0070] Referring next collectively to FIGS. 6D, 6E, 6F, 6G and 6H,
there is depicted a further adaptation to instrument 10 for
attaching and detaching tip sleeves that substantially slide over
and cover each or either of distal ends 48 and 28 in order to
provide the practitioner with different optional distal end tips
such as those depicted in FIG. 6A or otherwise well-known in the
reference art. The figures collectively teach the adaptations to
instrument 10 and introduce new tip sleeves, trays for holding tip
sleeves, boxes for holding trays and racks for holding boxes.
[0071] Referring next exclusively to FIG. 6D there is shown a
perspective drawing of the distal end of instrument 10, where
distal end 48a and 28a have been further adapted to include latches
48a-l and 28a-l, respectively, for securing tip sleeves 49a and
29a, respectively, and where sleeves 49a and 29a further include
interior companion latches (not depicted) for engaging latches
48a-l and 28a-l and exterior companion latches 49a-l and 29a-l for
engaging a tray (see FIG. 6E). As will be well understood by those
familiar with mechanical systems, there are many types of latches,
especially those including spring action, the many of which are
sufficient for the present purposes. In one embodiment as herein
depicted, the distal end latch such as 48a-l comprises an
indentation of some shape into which the interior companion latch
(not depicted) within tip sleeve such as 49a at least partially
engages, or enters, as the tip sleeve 49a is slide onto and over
the distal end such as 48a. For example, the interior companion
latch of sleeve 49a could be a ball mounted with an opposing spring
essentially pushing the ball in the direction of the surface of
distal end 48a comprising latch 48a-l. In this regard, the exact
shape of distal end 48a, as well as the location on the surface of
48a, wherein a securing latch such as 48a-l (and therefore also its
companion latch within sleeve 49a) is located is not restricted, as
many options are available and possible. Furthermore, the number of
latches 48a-l (where two are depicted although only one is labeled)
and companion latches within sleeve 49a is also optional. What is
most important to see is that: 1) the latch such as 48a-l operates
automatically to engage the companion latch comprised within the
respective tip sleeve such as 49a, for example in response to the
sliding on and over of a tip sleeve such as 49a, and 2) the latch
or latches such as 48a-l as well as the companion latches within
sleeve 49a, in any form, number or combination, causes what is
herein referred to as a sleeve holding pressure, and that
collectively the latches operate together as a securing means for a
replace tip such as 49a.
[0072] As a careful consideration of the teachings herein provided
will see, in the normal uses anticipated for instrument 10, there
is anticipated to be minimal forces opposing this sleeve holding
pressure, but in any case the types, forms, locations, or number of
implemented securing latches may be designed and implemented
accordingly such that the combined sleeve holding pressure is
sufficient to ensure that a tip sleeve such as 49a remains securely
attached to its companion distal end such as 48a after engagement
and during normal operation of the present instrument 10.
[0073] Still referring to FIG. 6D, it is possible that a given
latch operates at least in part using a magnet either or both
located or secured within the distal end such as 48a or the tip
sleeve such as 49a. Still other considerations will show that the
tip sleeve such as 49a may have alternate designs where the sleeve
includes interior posts substantially oriented in the direction of
engagement, and that these interior posts slid into interior post
holes co-located within the distal end such as 48a. Conversely, the
posts could be included on the distal end such as 48a, whereas the
post holes could be co-located within the sleeve such as 49a. One
advantage of the present depiction of latches such as 48a-l (of
some type and in some form, location and number) as opposed to the
co-location of one or more posts and post holes is that using this
latch type design the existing distal end 48a may include a usable
tip-type of its own, such as the pointed tips as shown (see also
FIG. 1), as long as this usable tip is able to slide within a given
tip sleeve such as 49a. Given the considerations and teachings of
FIG. 6D, it should therefore be understood that the present
depictions and descriptions are exemplary and should not be
considered as limitations of the present invention as many
variations are possible and anticipated as within the scope of the
present invention.
[0074] Referring next to FIG. 6E, there is shown a perspective
drawing of sleeve box 70, comprising sleeve trays 49a-t and 29a-t
for receiving, holding and discharging any of sleeves 49a and 29a,
respectively. Each tray 49a-t and 29a-t such as 49a-t preferably
further comprises a first tray cavity 49a-tc1 for holding the
non-tip portion of a sleeve such as 49a, a second tray cavity
49a-tc2 for holding the tip portion of a sleeve such as 49a, an
interior latch 49a-tl for impeding the lateral exit motion of a
sleeve such as 49a and a lateral tray entrance 49a-te for receiving
and discharging the distal end of instrument 10 such as 48a being
either inserted into or removed from a sleeve such as 49a held
within tray 29a-t, all of which is further best understood in light
of upcoming FIGS. 6F and 6G. Similar to the discussions respective
of distal end latches such as 48a-l and 28a-l and corresponding
interior companion latches (not depicted) located within tip
sleeves 49a and 29a, it is possible that for example tip sleeve 49a
exterior companion latch 49a-l (see FIG. 6D) and corresponding
interior latch 49a-tl of tray 49a-t be of many various types,
forms, locations and multiplicities.
[0075] As a careful consideration will show, the presently depicted
tray interior latch 49a-tl forms a lip segregating the portion of
tray 49a-t serving as the tray entrance 49a-te (that is therefore
narrower in dimension) from the portion of the tray 49a-t serving
as the first cavity 49a-tc1 (that is therefore wider in dimension),
all as depicted. Given such an arrangement as depicted, and as
further shown with respect to upcoming FIGS. 6F and 6G, the use of
the present lip 49a-tl restricts the movement of any tip sleeve
such as 49a resting within tray cavities 49a-tc1 and 49a-tc2 from
being extracted from the tray in a lateral motion with respect to
the tray's longitudinal axis, where this extraction is essentially
impeded by the narrowed potion of tray entrance 49a-te with respect
to the wider potion of tray cavity 49a-tc1.
[0076] Still referring to FIG. 6E, those familiar with latches
specifically and mechanical systems in general will understand that
many variations are possible while staying within the spirit of the
present invention. What is important to see is that any tip sleeve
such as 49a has an entrance/exit path into the corresponding
cavities 49a-tc1 and 49a-tc2 of tray such as 49a-t of box 70 that
is limited to a specific and substantially unimpeded direction, in
this case perpendicular to the longitudinal axis of tray 49a-t of
box 70 (see especially upcoming FIG. 6G for further discussion). As
a careful consideration will show, the present and preferred design
provides first and second cavities 49a-tc1 and 49a-tc2 sufficient
for receiving the entirety of a tip sleeve such as 49a being
lowered into (or raised from) tray 49a-t substantially unimpeded in
the perpendicular direction with respect to the longitudinal axis
of tray 49a-t. What is also important to see is that while resting
within tray 49a-t, tip sleeve 49a can be either engaged or
disengaged by a distal end of instrument 10, such as distal end 48,
where this direction of engagement/disengagement is substantially
different from the direction of removal/replacement (see FIG. 6G),
for example being an lateral direction with respect to the
longitudinal axis of tray 49a-t, where as depicted the lateral
direction is substantially parallel to the longitudinal axis of
tray 49a-t and therefore also substantially orthogonal to the
perpendicular path of removal/replacement.
[0077] As will be clear from a careful consideration of the present
FIG. 6E and related FIGS. 6D, 6F and 6G, tray latch 49a-tl
effectively provides a resistive impedance for overcoming the
combined sleeve holding pressure as prior described in relation to
FIG. 6D, such that when the distal end such as 48a is being
extracted from a corresponding and currently engaged sleeve 49a,
where the sleeve 49a is already resting within tray 49a-t, the tip
sleeve 49a is thereby caused by the resistive impedance of tray
latch 49a-tl to disengage from the distal end 48a such that the
distal end 48a is extracted from within the sleeve 49a, within the
tray 49a-t, exiting through tray entrance 49a-te, whereas the tip
sleeve 49a remains situated within the tray 49a-t. It should be
noted that the resistive force available from tray latch 49a-tl is
dependent upon the forces that secure box 70 to a surface upon
which box 70 is resting during the normal use of the proposed box
70. For example, box 70 may be resting upon a rubberized mat on a
table where the rubberized mat provides a frictional force that
sufficiently exceeds the combined sleeve holding pressure (force)
such that the box 70 does not slip or slid across the resting
surface during the extraction of a distal end such as 48a from a
sleeve such as 49a. Alternatively, the box 70 could be attached or
mounted to the resting surface below the box, or even heavily
weighted, where many variations are possible as will be well
understood by those familiar with mechanical systems, all of which
are considered within the scope and spirit of the present
invention.
[0078] Still referring to FIG. 6E, it is preferable but not
mandatory that the end of box 70 comprising entrances such as
49a-te be of a greater first height 70-h1 respective to a lesser
second height of 70-h2 corresponding to the opposite end of box 70
comprising second cavities such as 49a-tc2. As a careful
consideration of the present teachings will make clear, given this
disparity between heights 70-h1 and 70-h2, box 70 will essentially
appear to a practitioner situated on the entrance side (comprising
49a-te) of box 70 to lean down and away. As will also be clear
based upon a mental visualization of the hand motions required of
the practitioner with respect to the use of instrument 10 with
respect to tray 70, the practitioner must rotate the instrument 10
such that the distal ends 48a and 28a are aligned side-by-side with
respect to the surface upon which box 70 resides, where in this
alignment it is preferred that the practitioner's hand is facing
palm-up verses palm-down.
[0079] In such a palm-up orientation, the fingers and knuckles of
the practitioner's hand that is holding instrument 10 are facing
substantially downward and therefore not obscuring the view of the
practitioner with respect to the box 70 and sleeves such as 49a and
29a resting within the box 70. Furthermore, a careful consideration
will also show that by leaning the trays such as 49a-tc1 downward
and away from the practitioner and the entrance such as 49a-te of
box 70 (corresponding to height 70-h1 being greater than 70-h2),
additional clearance space is provided for the downward facing
fingers and knuckles of the practitioner's hand that is holding
instrument 10. Other alternative box 70 constructions are possible
without departing from the spirit of the present invention and the
core teachings provided herein. For example, the heights 70-h1 and
70-h2 could be substantially similar (or even reversed where height
70-h2 exceeds height 70-h1) and the box 70 could be adapted to
situated at the edge of a mounting surface (such that the
practitioner's fingers do not encounter the surface as the
practitioner's hand moves the distal ends 48a and 28a of instrument
10 into their respective tray entrances such as 49a-te (and a
similar 29a-te not depicted). Alternatively, the box 70 could have
downward facing mounting posts or be enlarged to increase the
effective distance between the bottommost interior height of a tray
such as 49a-t and the surface upon which the box 70 is situated,
thereby also or additionally creating further clearance for the
practitioner's downward facing fingers. And finally, its is
possible that box 70 comprise a single tray such as 49a-t and
therefore comprises no second tray such as 29a-t, wherein for
example instrument 10 has only a single replaceable distal end such
as 48a (and therefor 28a is obviated in favor of distal end 28
without securing means) or both distal ends 48a and 28a are
included in instrument 10 where the practitioner chooses to fasten
a single tip sleeve such as 49a at a time, where it should then be
seen by a careful consideration that a single tray such as 49a-t
holding a single sleeve such as 49a could service either distal end
such as 48a or 28a. Thus, the presently depicted box 70 (and
upcoming rack of boxes 72 shown in FIG. 6H) should be considered as
exemplary, rather than as a limitation of the present invention as
many variations are possible and anticipated without departing from
the spirit of the invention.
[0080] Referring next to FIG. 6F, there is shown a perspective view
of instrument 10 further adapted as described in FIG. 6D to
comprise distal ends 48a and 28a partially inserted into sleeves
49a and 29a, respectively, where sleeves 49a and 29a are being held
within trays 49a-t and 29a-t, respectively, comprising sleeve box
70 as described in FIG. 6E. The purpose of FIG. 6F is to provide an
additionally clarifying perspective view of tray 70 as described in
FIG. 6E holding tip sleeves 49a and 29a as described along with
partially inserted instrument 10 distal ends 48a and 28a all as
described in FIG. 6D.
[0081] Referring next to FIG. 6G, there is shown a side view
diagram depicting three steps 1, 2 and 3 for first inserting (steps
1 and 2) via substantially a lateral motion distal ends such as 48a
comprising latch 48a-l into sleeves such as 49a held within sleeve
box 70, and second removing (step 3) via substantially a
perpendicular motion sleeves such as 49a now secured via an
interior latch (not depicted) to a distal end latch such as 48a-l,
where in the perpendicular motion exterior latch 49a-l of sleeve
49a is substantially unimpeded by tray box 70, and where the
combination of steps 1, 2 and 3 is pictorially shown as "engage"
and "remove". Whereas steps 1, 2 and 3 allow for the engagement and
removal of sleeves such as 49a from the tray box 70 by instrument
10, a reversal of steps 1, 2 and 3 further allow for the
"replacement" and "disengagement" of sleeves such as 49a from tray
box 70 by instrument 10, wherein during the reversal of step 3 tray
box 70 substantially impedes the removal of a sleeve such as 49a by
catching exterior companion latch 49a-l during the extracting
lateral motion, thereby disengaging a sleeve such as 49a from a
distal end such as 48a.
[0082] Referring next to FIG. 6H, there is shown a side-perspective
view of a tray rack 72 for example comprising three tray boxes
70-1, 70-2 and 70-3, where instrument 10 is depicted as removing
(or replacing) sleeves from tray box 70-1 in accordance with the
steps 1, 2 and 3 described FIG. 6G. As will be obvious to those
skilled in the arts for which the instrument and tip sleeves are
intended, such as but not limited to one or more medical or
non-medical applications including the lacrimal occlusion
procedure, the number of trays such as 70-1, 70-2 and 70-3 in a
given rack such as 72 may be varied as desirable without departing
from the scope and spirit of the present invention. Many other rack
72 designs are possible, where the number and size of trays such as
70-1 are varied, as well as their relative arrangements. It is not
mandatory that the racks such as 70-1, 70-2 and 70-3 are in a
horizontal arrangement and can alternately or additionally be
provided in a vertical arrangement, although such an arrangement
must necessarily leave sufficient space over each tray for ease of
tip sleeve replacement and removal. Therefore, the presently
depicted rack 70 should be considered as exemplary, rather than as
a limitation of the present invention, as many other configurations
of trays are possible and anticipated.
[0083] Referring next collectively to FIGS. 7A, 7B, 8A, 8B, 9A, 9B,
10A and 10B, there are depicted four different mechanisms for
providing the function of clamp-limiting, where the holding surface
10d is mechanically blocked from completely closing given the
absence of any engaged plug such as 60 or 61. As prior discussed,
unlike thumb forceps where the closing pressure is applied by the
practitioner as a continuous pressure to be maintained throughout
at least the plug insertion step 106 (see FIG. 2), the present
instrument 10 provides inherent positive (closing) pressure between
distal ends 28 and 48 such that the practitioner only maintains
holding pressure to maneuver the instrument 10 during plug
insertion step 206 (see FIG. 3), regardless of the form of the
distal ends such as pointed, rounded, curved, or any of the various
reference art shapes including those depicted in FIG. 6A, and
regardless of the type of the distal ends such as permanent (FIG.
1) versus detachable (FIG. 6B, 6C, 6D, 6F and 6G). As those
familiar with plugs and the lacrimal occlusion medical procedure,
as well as other medical procedures for which a clamping action is
desired, the ability to limit the clamping pressure for example
when engaging a larger sized plug made of a softer material has
significant advantages.
[0084] Referring next exclusively to FIG. 7A, there is shown distal
end 48b that has been further adapted to include a first
clamp-limiting screw type mechanism that includes a knob 48b-k for
turning by the practitioner. As those familiar with screw action
will understand, as the practitioner turns the knob 48b-k both the
knob 48b-k and screw 48b-s extending from the knob 48b-k are either
lowered into the holding space between distal ends 48b and 28 or
are raised out of the holding space between distal ends 48b and 28.
As will be clear from a careful consideration of the present
figure, the length of the screw 48b-s present in the holding space
has a proportional effect on the tip gap between the distal ends,
such that by limiting the tip gap to some non-zero amount, where
with a zero amount gap distal end 48b comes into contact with
distal end 28, it is possible to thereby limit the clamping
pressure.
[0085] Referring next exclusively to FIG. 7B, distal end 48b has
been further adapted to include markings 48b-m including 48b-m1,
48b-m2, 48b-m3 and 48b-m4 for corresponding with sizer markings
such as 51-m1, 51-m2, 51-m3 and 51-m4, respectively (see also FIG.
4A). Preferably, markings 48b-m also include a marking 48b-m0
representing a zero-amount gap (that does not have a corresponding
51-m0 marker), where marking 48b-m0 represents the fully closed tip
gap as opposed to markings 48b-m1, 48b-m2, 48b-m3 and 48b-m4, each
corresponding to some non-fully-closed tip gap. As will be clear
from a careful consideration of the present figure, by arranging
the markings 48b-m around the knob 48b-k and by including a mark on
the top surface of the knob for indicating the current turning
position (see the dark triangle), it is possible to provide the
practitioner with a visible indication as to the amount of knob
turning necessary to reach a desired tip gap based upon for example
the size of the punctum as determined using a sizer-dilator 51 with
markings 51-m1, 51-m2, 51-m3 and 51-m4. As will be clear to those
familiar with mechanical systems and medical tools, other
variations of markings such as 48b-m are possible without departing
from the spirit of the invention, and as such the present markers
depicted, including the number of markings such as 48b-m0, 48b-m1,
48b-m2, 48b-m3 and 48b-m4, as well as at least the color, size,
shape and location of the markings 48b-m should be considered as
exemplary, rather than as a limitation of the present
invention.
[0086] Referring next collectively to FIGS. 8A, 8B, 9A, 9B, 10A and
10B, it is herein noted that for the sake of clarity and focus on
the depicted clamp-limiting mechanisms, no markings like 48b-m such
as 48b-m0, 48b-ml, 48b-m2, 48b-m3 and 48b-m4 have been depicted in
these upcoming figures. However, the present invention anticipates
the use of some type of markings such as 48b-m depicted in FIG. 7B
for each of the various clamp-limiting means herein taught with
respect to FIGS. 8A, 8B, 9A, 9B, 10A and 10B, such that regardless
of the type of clamp-limiting means implemented in the instrument
10, markings such as 48b-m are made available to assist the
practitioner with setting the mechanical clamp-limiting mechanism
to correspond to a determinized size of for example a punctum
orifice. As will be clear upon a careful consideration of the
upcoming clamp-limiting means as depicted in FIGS. 8A, 8B, 9A, 9B,
10A and 10B, many variations of markings such as 48b-m are possible
and further anticipated within the spirit of the present
teachings.
[0087] Referring next to FIGS. 8A and 8B, there is shown an
alternative distal end 48c that has been further adapted to include
mechanical means for limiting the clamping pressure of instrument
10, where the mechanical means is a sliding wedge 48c-w that is
moved forward by the practitioner pushing the sliding wedge knob
48c-k towards the distal end of instrument 10 to widen the tip gap
(and therefore further limit the closing pressure), and is moved
backward by the practitioner pulling the sliding wedge know 48c-k
away from the distal end of instrument 10 to narrow the tip gap
(and therefore further increase the closing pressure).
[0088] Referring next to FIGS. 9A and 9B, there is shown an
alternative distal end 48d that has been further adapted to include
mechanical means for limiting the clamping pressure of instrument
10, where the mechanical means is a rotating oblong wheel 48d-w
that is rotated for example clockwise by the practitioner likewise
rotating knob 48d-k clockwise to widen the tip gap (and therefore
further limit the closing pressure), and is rotated for example
counter-clockwise by the practitioner likewise rotating knob 48d-k
counter-clockwise to narrow the tip gap (and therefore further
increase the closing pressure).
[0089] Referring next to FIGS. 10A and 10B, there is shown
alternative wide portions 24e and 44e comprising grasping surface
10b that have been further adapted to include mechanical means for
limiting the clamping pressure of instrument 10, where the
mechanical means is pivoting rachet arm 44e-r pivotally attached to
wide portion 44e that slides through an opening in wide portion 24e
as the practitioner exerts an opening pressure (as prior described
in relation to FIG. 1) upon wide portions 24e and 44e so as to
reduce the arm space and inversely increase the tip gap, and where
the mechanical means further includes a return pressure means such
as spring 24e-s located within the opening in wide portion 24e that
applies return pressure upon rachet arm 44e-r so as to cause rachet
arm 44e-r to catch and re-catch upon wide portion 24e, all as will
be well understood by those familiar with a rachet mechanism. The
effect of the operation of rachet 44e-r and spring 24e-s is that as
the practitioner releases the applied opening pressure upon wide
portions 24e and 44e spring 24e-s causes the rachet 44e-r to catch
up wide portion 24e such that the normal inherent closing
(positive) pressure of the bulldog forceps is impeded, thus fixing
the arm space and therefore tip gap at a distance substantially
determined by the extent of the opening pressure applied by the
practitioner. In order to restore the maximal closing (positive)
pressure inherent within the design of instrument 10, the
practitioner exerts a forward pressure upon the portion of rachet
44e-r protruding through the opening in wide portion 24e that moves
the rachet 44e-r forwards towards the distal end of instrument 10,
where this exerted forward pressure counteracts and overcomes the
return pressure applied by spring 24e-s thus allowing wide portions
24e and 44e to fully separate increasing the arm space to a maximum
while inversely decreasing the tip gap to a minimum.
[0090] Referring next to FIGS. 11A and 11B, the distal ends 28 and
48 of rachet type clamp-limiting medical instrument 10 as taught in
relation to FIGS. 10A and 10B have been further adapted as distal
ends 28tip2 and 48tip2 including tissue separating style tips. As
those familiar with medical instruments will understand, there are
multiple designs currently known and otherwise possible for
facilitating the tissue separating function and therefore the
present depictions should be considered as exemplary rather than as
a limitation of the presentation invention. What is important to
see is that the medical instrument 10 that has been further adapted
with a rachet style clamp-limiting means such as taught in relation
to FIGS. 10A and 10B provides a means for separating tissue
substantially proportional to the amount of opening pressure
applied by a practitioner to wide portions 24e and 44e, where
increased opening pressure causes increased separating pressure
applied on the tissue (or matter to be separated) by distal tips
28tip2 and 48tip2. Once a preferred tissue separation pressure and
therefore also tissue separation distance has been achieved by the
practitioner in operation of the further adapted instrument 10 as
presently depicted and described especially in relation to FIGS.
10A and 10B, the included rachet mechanism serves to lock-in the
substantially final separation of distal end 28tip2 and 48tip2.
Also, as prior discussed, the practitioner releases this final
applied separating pressure thus reducing the final achieved
separating distance between distal end 28tip2 and 48tip2 by
exerting a forward pressure upon the portion of rachet 44e-r (see
the teachings in relation to FIGS. 10A and 10B), thus disengaging
the rachet.
CONCLUSION AND RAMIFICATIONS
[0091] Thus, as the reader can see, the present two-in-one
inventive medical instrument 10 and lacrimal occlusion process 200
includes at least the following improvements with respect to
process traditional process 100: 1) increasing the continuous
concentration and focus of the practitioner thus reducing the
likelihood of inadvertent physical harm to the patient; 2) reducing
the practitioner's physical muscle stresses and potential attendant
hand shaking by eliminating the need for applying continuous
closing pressure while simultaneously moving the instrument 10 for
plug insertion; 3) reducing the overall mental stresses on both the
patient and the practitioner; 4) reducing the likelihood of
dropping plugs and therefore decreasing the average material cost
to the practitioner, and 5) reducing the average process time
duration and therefore also average time cost to the practitioner.
Other important benefits have been detailed herein and will be
obvious to those skilled in the art of lacrimal occlusion.
[0092] Furthermore, based upon the further adaptation of medical
instrument 10 providing for a combined sizer-dilator 51, and thus a
three-in-one tool, the reader can see that the lacrimal occlusion
process 300 includes at least the following improvements with
respect to process 200: 1) further increasing the continuous
concentration and focus of the practitioner thus reducing the
likelihood of inadvertent physical harm to the patient; 2) further
reducing the overall mental stresses on both the patient and the
practitioner, and 3) further reducing the average process time
duration and therefore also average time cost to the
practitioner.
[0093] As the reader will also see, the present instrument 10
further provides for permanent or detachable proximal or distal
ends, where for example based upon the orientation of the
instrument 10 the proximal ends could be a dilator 50 or a
sizer-dilator 51 and the distal ends could be any of various end
tips such as 48-tipl or 28-tip1, or end tip sleeves such as 49a or
29a, where the shape and function of these various end tips and tip
sleeves can at least match any of the shapes and functions
currently used in the reference art for various medical procedures
including lacrimal occlusion, trichiasis, and tissue separation.
Those skilled in other non-medical arts will recognize that the
many teachings of the present invention provide significant
benefits for non-medical uses. With respect to the detachable
distal end sleeves 49a and 29a, the present reader will also see
that a new system has been provided for allowing the practitioner
to efficiently select, replace or switch between a number of
different end tip sleeves using only a single hand, thus further
facilitating the optimization of at least medical procedures such
as lacrimal occlusion. This new system comprises at least one box
70 comprising two trays 49a-t and 29a-t, where each tray holds a
replaceable sleeve 49a or 29a, respectively, for one of the
instrument's 10 distal ends such as 48a or 28a, respectively. It is
further anticipated herein that this same teaching for replaceable
distal end tips complete with the rack, box and tray system, is
also applicable for implementation with the detachable proximal
ends, hence supporting multiple dilators or sizer-dilators. This
anticipated further adaptation thus additionally provides for
allowing the practitioner to efficiently select, replace or switch
between a number of different dilators or sizer-dilators using only
a single hand. In one distinction, the proximal end tray system
only requires one tray per box, as will be obvious to the careful
reader.
[0094] And finally the reader will also see that the present
teachings provide mechanical means for allowing the practitioner or
user of the instrument 10 to limit the inherent closing (positive)
pressure applied by the end tips, where this clamp-limiting is
useful both to set the smallest tip gap (for example for use in a
grasping function) and to maintain the largest tip gap (for example
for use in a separating function.)
[0095] The careful reader familiar with the necessary technologies
for manufacturing instruments such as described herein will
understand that many embodiments are possible for implementing the
functional teachings of the present invention. As such, it will be
well understood that the preferred and alternate embodiments of the
presently taught apparatus and methods, as well as the many taught
use cases, should be considered as exemplary, rather than as
limitations to the present invention. While certain features of the
invention have been illustrated and described herein, other
modifications and changes will occur to those skilled in the art.
It is, therefore, to be understood that the appended claims are
intended to cover all such modifications and changes as fall within
the true spirit of the invention.
* * * * *